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Pembrolizumab Plus Lenvatinib in Vulvar Cancer Patients: MITO VULVA-01

NCT07290894 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-02

No results posted yet for this study

Summary

MITO VULVA-1 is a prospective, single arm, multi-cohorts, phase II trial that aims to assess the activity and the safety of Lenvatinib plus Pembrolizumab in patients with vulvar cancer. 80 patients will be overall enrolled in the study.Three cohorts are planned

Conditions

  • Vulva Cancer

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg IV infusion (30 minute) is administered at Day 1 of each 21-days cycle.Pembrolizumab will be administered up to 35 cycles.

DRUG

Lenvatinib Capsules

.Lenvatinib 20 mg (two 10-mg capsules) QD will be taken orally with water (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each Pembrolizumab cycle, Lenvatinib will be administered within 1 hour after Pembrolizumab.

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Sandro Pignata, MD, PhD · National Cancer Institute,IRCCS, Fondazione G. Pascale, Naples , Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-12
Primary Completion
2031-10-31
Completion
2031-10-31

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290894 on ClinicalTrials.gov